To establish the safety and efficacy of the XIENCE PRIME or XIENCE V or XIENCE Xpedition or XIENCE PRO Everolimus Eluting Coronary Stent System (EECSS) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

Notes:

XIENCE Xpedition and XIENCE PRO are newly added to the XIENCE Family Stent System.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Protocol-defined is an identical definition for MI after both PCI and CABG to eliminate ascertainment bias. Only prognostically important MI that has clearly been associated with subsequent mortality will be included in the primary endpoint.

Ability to sign informed consent and comply with all study procedures including follow-up for at least three years

Exclusion Criteria:

* Clinical exclusion criteria:

Prior PCI of the left main trunk at any time prior to randomization

Prior PCI of any other coronary artery lesions within one year prior to randomization

Prior CABG at any time prior to randomization

Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed

Any recent MI with CK-MB levels still elevated

Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year

Subjects requiring or who may require additional surgery within one year

The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present

The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present

Pregnancy or intention to become pregnant

Non cardiac co-morbidities with life expectancy less than 3 years

Other investigational drug or device studies that have not reached their primary endpoint

Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention

Angiographic exclusion criteria:

Left main diameter stenosis <50%

SYNTAX score ≥33

Left main reference vessel diameter <2.25 mm or >4.25 mm

The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present

The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205776